Paravertebral catheter versus Epidural analgesia in Minimally Invasive Esophageal Resection: a randomized controlled multicenter trial (PEPMEN trial)
- Conditions
- 100179901001799110017998esophageal cancer
- Registration Number
- NL-OMON54619
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 199
The study population consists of patients who are scheduled to undergo elective
minimally invasive esophagectomy with two-field lymphadenectomy, gastric
conduit reconstruction, and intrathoracic anastomosis (i.e. Ivor Lewis
procedure).
- ASA >III / severe comorbidity
- Coagulation disorders that prohibit epidural analgesia according to the
Nederlandse Vereniging voor Anesthesiologie (NVA) guideline *Neuraxisblokkade
en antistolling*
- Other contraindications for epidural analgesia
- Allergy to local anesthetics
- Ongoing opioid use (i.e. any opioid) prior to esophagectomy (i.e. >3 months
calculated until the day of esophagectomy)
- Renal failure, i.e. eGFR < 50
- Unable to complete questionnaires in Dutch
- Cervical lymph node dissection (i.e. 3-field lymphadenectomy)
- Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is the quality of recovery on postoperative day 3,<br /><br>measured by the *Quality of Recovery - 40 (QoR-40)* questionnaire.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures include the need for escape pain medication,<br /><br>additional opioid consumption, technical complications, length of intensive<br /><br>care and hospital stay, postoperative complications, quality of life at 3 and<br /><br>6 months after surgery, pain at 6 months after surgery, and cost-effectiveness.</p><br>